Methods and apparatus for assessing sleep quality

ABSTRACT

Systems and/or methods for assessing the sleep quality of a patient in a sleep session are provided. Data is collected from the patient and/or physician including, for example, sleep session data in the form of one or more physiological parameters of the patient indicative of the patient&#39;s sleep quality during the sleep session, a subjective evaluation of sleep quality, etc.; patient profile data; etc. A sleep quality index algorithm, which optionally may be an adaptive algorithm, is applied, taking into account some or all of the collected data. Sleep quality data may be presented to at least the patient, and it may be displayed in any suitable format (e.g., a format useful for the patient to be appraised on the progress of the treatment, a format useful for a sleep clinician to monitor progress and/or assess the effectiveness of differing treatment regimens, etc).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 16/385,893, filed Apr. 16, 2019, now allowed, which is acontinuation of U.S. application Ser. No. 14/085,327, filed Nov. 20,2013, now U.S. Pat. No. 10,300,230, which is a continuation of U.S.application Ser. No. 12/311,361, filed on Oct. 6, 2009, now U.S. Pat.No. 8,617,068, which claims benefit to PCT Application No.PCT/AU2007/001440, filed on Sep. 27, 2007, and Australian ProvisionalPatent Application No. 2006905343, filed on Sep. 27, 2006, the entirecontents of which are hereby incorporated herein by reference.

FIELD OF THE INVENTION

The exemplary embodiments disclosed herein relate to methods andapparatus for treatment of sleep disorders, including, for example,sleep disordered breathing (SDB), and for assessment and communicationof sleep quality.

BACKGROUND OF THE INVENTION

Excessive daytime sleepiness (EDS) is widespread throughout thepopulation, interfering with day-to-day activities, work, andrelationships. EDS reduces productivity, concentration, memory, and cannegatively impact on mood, and may cause danger to the community bythose affected driving or operating machinery while drowsy.

Daytime sleepiness may be caused by an underlying medical condition suchas sleep disordered breathing, by insufficient sleep resulting from poorsleep hygiene, self-imposed or socially dictated sleep deprivation, etc.

There have been attempts to quantify sleepiness, or to assess sleepquality.

Introspective behavioral scales and performance tests have been used tomeasure sleepiness and use subjective scales to query the individual'sperception of alertness/sleepiness.

The Stanford sleepiness scale and Karolinska Sleepiness Scale assess themomentary degree of alertness/sleepiness. This is useful for a periodbut generally is less helpful in examining the global feelings ofsleepiness. Also, in order to achieve accurate results, a subjectiveevaluation that is representative of the entire period between treatmentsessions is needed.

The Epworth sleepiness scale (ESS) is a self-administered questionnaireused to determine the subject's general level of daytime sleepiness.Participants are asked to rate the likelihood that they would fallasleep in a range of common everyday situations. A rating of 0 meansthat the subject would never fall asleep compared to 3, meaning there isa high chance of dozing or falling asleep.

The summation of these ratings is the ESS score—an Epworth score of 0 isnon-sleepy, 10 or more is considered sleepy, and 18 or more is verysleepy.

The Pittsburgh Sleep Quality Index (PSQI) is another method fordetermining sleep quality and sleep disturbances. The PSQI is aself-rated questionnaire which assesses sleep quality and disturbancesover a 1-month time interval. Nineteen individual items generate seven“component” scores: subjective sleep quality, sleep latency, sleepduration, habitual sleep efficiency, sleep disturbances, use of sleepingmedication, and daytime dysfunction. The sum of scores for these sevencomponents yields one global score. The higher scores generallycorrelated with greater sleep complaints and therefore diminishedquality.

Another new method of measuring perceived sleepiness is to use pictorialscales which depict cartoon pictures of different degrees of tiredness.

Objective tests to measure sleepiness include Pupillography, theMultiple Sleep Latency Test (MLST), and Maintenance of Wakeful test.

Pupillography is based on changes in pupil stability that corresponds tothe level of alertness. This technology is currently used in devicesthat are designed to prevent driver fatigue.

The Multiple Sleep Latency Test (MSLT) provides a valid measure ofdaytime sleepiness on the particular day of the test. This test is basedon the premise that the sleepier the subject, the faster they will fallasleep when encouraged to do so while lying down in a non-stimulatingenvironment (Johns 1991). The MSLT includes four to five opportunitiesto nap spaced across the day at 2-hour intervals. The MSLT is verycumbersome, time consuming, and expensive to perform, as it takes allday.

The Maintenance of Wakeful test is similar to the MSLT and asks patientsto try to remain awake for as long as possible. It is currently used forlegal purposes to determine if someone suffers from excessive daytimesleepiness.

However, for these methods to be useful tools for improving thepatient's sleep, the patient must have insight into the problem and beable to distinguish between sleepiness from other factors affectingperformance.

There have also been objective measurements of the patient's sleepquality.

In U.S. Publication No. 2005/0267362, an assessment of sleep quality andsleep disordered breathing is determined from cardiopulmonary couplingbetween two physiological data series—an R-R interval series derivedfrom an electrocardiogram (ECG) signal, and an ECG-derived respirationsignal.

In U.S. Pat. No. 6,120,441 (Griebel), various sensors detect a patient'sbody functions which are stored in a recorder. The stored data is thentransferred to a computer where it is analyzed and evaluated.

U.S. Pat. No. 6,468,234 (Van der Loos et al.) describes a method andapparatus for measuring sleep quality that utilizes sensors incorporatedin a sheet which is laid on top of a conventional mattress on which thesubject sleeps, interface software for collecting user lifestyle data,and lifestyle correlation software for correlating the lifestyle datawith the data acquired by said array of sensors.

U.S. Pat. No. 6,878,121 (Krausman et al.) describes a device which usesa motion sensor to measure the movement of a patients arm during sleepand then produces a sleep score based on these movements.

However, the existing arrangements can be improved upon in terms ofsufficiency of measurement and feedback to the patient regarding theirsleep.

SUMMARY OF THE INVENTION

In certain example embodiments, a method of assessing sleep quality of apatient in a sleep session is provided. Sleep session data comprisingtwo or more measured physiological parameters of the patient which areindicative of the patient's sleep quality during the sleep session isobtained. A composite sleep quality index is calculated from said two ormore sleep session data parameters (e.g., determined over a periodcomprising two or more sleep sessions). The composite sleep qualityindex is communicated to the patient.

In certain other example embodiments, a method of assessing sleepquality of a patient in a sleep session is provided. Sleep session datacomprising one or more measured physiological parameters of the patientwhich are indicative of the patient's sleep quality during the sleepsession is obtained. A score index is derived from the sleep sessiondata parameter and patient feedback data from previous sleep sessions(which may be electronically recorded). The score index is communicatedto the patient.

In certain other example embodiments, a method of assessing sleepquality of a patient in a sleep session is provided. Sleep session datacomprising one or more measured physiological parameters of the patientwhich are indicative of the patient's sleep quality during the sleepsession is obtained (e.g., recorded and stored electronically). A scoreindex is derived from the sleep session data parameter and patientprofile data. The score index is communicated to the patient.

In certain other example embodiments, a method of assessing sleepquality of a patient in a sleep session is provided. Sleep session datacomprising one or more measured physiological parameters of the patientwhich are indicative of the patient's sleep quality during the sleepsession is obtained. A score index is derived from the sleep sessiondata parameter and optimal sleep characteristics data for the patient.The score index is communicated to the patient.

In certain other example embodiments, a method of assessing sleepquality of a patient in a sleep session is provided. Sleep session datacomprising two or more measured physiological parameters of the patientwhich are indicative of the patient's sleep quality during the sleepsession is obtained. Subjective patient feedback data is obtained. Acomposite sleep quality index is calculated using said sleep sessiondata and said patient feedback data. The composite sleep quality indexis communicated to the patient.

In certain other example embodiments, an apparatus for assessing sleepquality of a subject, including apparatus for supplying breathable gasunder pressure to the subject for treatment of sleep disorderedbreathing, is provided. One or more sensors is/are configured to measuresleep session data comprising a plurality of physiological parameters ofthe patient which are indicative of the patient's sleep quality duringthe sleep session. A processor is configured to calculate a compositesleep quality index from said two or more sleep session data parameters.A display is provided to communicate the composite sleep quality indexto the patient.

In certain other example embodiments, a method of assessing sleepquality of a patient in a sleep session is provided. Sleep session datacomprising one or more physiological parameters of the patient which areindicative of the patient's sleep quality during the sleep session isobtained. Subjective patient data is obtained. A calculation is appliedto said sleep session data to calculate a sleep quality index indicativeof the quality of the patient's sleep, said calculation being dependenton said subjective patient data. The sleep quality index is communicatedto the patient.

In certain other example embodiments, a method of assessing sleepquality of a patient in a sleep session is provided. Sleep session datacomprising one or more physiological parameters of the patient which areindicative of the patient's sleep quality during the sleep session isobtained. Subjective patient data is obtained. A calculation is appliedto said sleep session data to calculate a sleep quality index indicativeof the quality of the patient's sleep. The sleep quality index iscommunicated to the patient, including adapting the form of saidcommunication dependent on said subjective patient data.

In certain other example embodiments, a method of assessing sleepquality of a patient whilst undergoing therapy for a sleep disorder isprovided. Sleep session data comprising one or more physiologicalparameters of the patient which are indicative of the patient's sleepquality during a sleep session in which the patient undergoes saidtherapy is obtained. Feedback is communicated to the patient regardingpatient's sleep quality during the sleep session, including providinginformation to the patient on improvements for future therapy sessions,said information being based on said sleep session quality for the sleepsession.

The information may include, for example, directions for adjustment oftherapy apparatus for future therapy sessions, such as adjustments to bemade to the patient interface, or directions for modification to therapysettings for future therapy sessions.

In another example embodiment, a flow generator of a sleep disorderedbreathing treatment device is provided. The flow generator comprises auser interface having an adjustment device comprising a knob, one ormore buttons, a lever, or the like, and a number of settings thatcorrespond to sleep ratings (e.g., a good night's sleep, a bad night'ssleep, tired, awake, etc.). The adjustment device is readily accessibleon the flow generator for use by the patient. The adjustment deviceincludes a first setting which transmits data to a control algorithm ofthe flow generator corresponding to the patient having slept well and asecond setting which transmits data to the control algorithmcorresponding to the patient having slept badly.

In certain example embodiments, a method of treating a patient for sleepdisordered breathing including the use of a flow generator is provided.Sleep data comprising one or more physiological parameters of thepatient indicative of the patient's sleep quality from a recordingdevice over at least one sleep session is obtained. Observations fromthe patient after the at least one sleep session are obtained, with theobservations being indicative of the quality of the patient's at leastone sleep session. A composite sleep quality value is calculated fromthe one or more physiological parameters and the observations from thepatient. A flow generator adjustment is calculated as a function of thecomposite sleep quality value. Parameters of the flow generator areadjusted in dependence on the calculated flow generator adjustment.

In certain example embodiments, a method of adjusting the treatmentpressure regime of a sleep disordered breathing treatment device isprovided. Observational data from a patient after one or more sleepssessions is electronically recorded and stored, with the observationaldata being indicative of the quality of the patient's one or more sleepssleep sessions. The sleep disordered breathing treatment device isadjusted on the basis of the observational data.

In certain example embodiments, an apparatus and/or system may beprovided for carrying out the above methods. Furthermore, the variousexample aspects and/or example embodiments described herein may be usedalone and/or in combination with other example aspects and/or exampleembodiments to realize yet further example embodiments.

For example, in certain example embodiments, a patient accessible inputdevice is provided. A user interface is configured to receive a patientinput from the patient corresponding to a perceived quality of sleep ofthe patient. A transmission device is configured to transmit the patientinput to a processor configured to adjust one or more parameters of aflow generator of a sleep disordered breathing treatment device tooptimize the treatment regime.

In certain example embodiments, a sleep disordered breathing treatmentsystem is provided. A user interface is configured to receive a patientinput from the patient corresponding to a perceived quality of sleep ofthe patient. A computer-readable storage device storescomputer-executable process steps for altering one or more treatmentalgorithms. A processor is operatively connected to the user interfaceand the storage device. When a patient provides a patient input into thesystem via the user interface, the processor is configured to executethe computer-executable process steps by which the one or more treatmentalgorithms are adjusted according to the patient input.

In certain example embodiments, there is provided an automaticallyadjusting flow generator comprising a user interface configured toreceive a patient's assessment of how well the patient has slept, withthe flow generator being configured to adjust its control algorithm inresponse to the patient's assessment to optimize therapy.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 illustrates the sleep cycle in healthy sleep;

FIG. 2 illustrates characteristic EEG results for the different stagesof sleep;

FIG. 3 is a graph showing the change in the proportion of REM sleep withage;

FIG. 4 is an overview of calculation of a sleep quality index inaccordance with an example embodiment;

FIG. 5 is an illustrative flowchart showing a process for determiningsleep quality index and communicating sleep quality data to at least apatient in accordance with an example embodiment; and

FIG. 6 is an illustrative block diagram showing an apparatus fordetermining sleep quality index and communicating sleep quality data toat least a patient in accordance with an example embodiment.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS 1. The Sleep Cycle

Sleep is best distinguished from quiet waking by changes in neuronalactivity patterns—as manifested in electroencephalogram (EEG)readings—and by loss of behavioral responsiveness.

The sleep cycle of a healthy sleep structure can be divided into the twoprinciple segments of Rapid Eye Movement (REM) sleep and Slow Wave Sleep(SWS). SWS sleep can then be further divided into four distinct phases,including stage 1, 2, 3, and 4, as illustrated in FIG. 1.

As can be seen in FIG. 1, as a person sleeps, the person progressesthrough the different stages of sleep in a cyclic manner. Across thenight, the average period of a total cycle is approximately 90-110minutes. If the subject is aroused, the subject returns to the awakestate and the cycle restarts.

Each stage has specific characteristics that are largely determined bymeasuring the electrical activity of the brain using anelectroencephalogram (EEG) apparatus. The EEG measures brainwaves ofdifferent frequencies within the brain by placing electrodes on specificsites of the scalp.

The raw EEG data is usually described in terms of frequency bands: Gamma(>30 Hz), BETA (13-30 Hz), ALPHA (8-12 Hz), THETA (4-8 Hz), and DELTA(less than 4 Hz).

Detection of each stage of sleep from the EEG readings may be done byapplying known criteria, such as those set out in “A Manual ofStandardized Terminology, Techniques and Scoring System for Sleep Stagesof Human Subjects” by Rechtschaffen and Kales (1968) and the proposedsupplements and amendments (Psychiatry and Clinical Neurosciences 2001,55, 305-310) (1996).

FIG. 2 shows typical EEG readings characteristics of each sleep stage.

The following is a brief outline of each of the sleep stages in healthysleep.

1.1 Sleep Onset

Sleep onset is the first epoch scored as one of the standard sleepstages (1, 2, 3, 4, and REM) after the lights are darkened or thepatient goes to bed.

1.2 Stage 1 Sleep

Stage one sleep is the transition between sleep and wakefulness and hasthe following characteristics. The EEG results indicative of stage 1 arelargely in the alpha ranges with EEG vertex spikes. No sleep spindles orK-Complexes are present. The eyes often move in a slow rolling movementand at this stage the arousal threshold is low. Body movement is commonduring the transition from the wakeful stage to the sleep stages. Stageone generally lasts between 1 and 10 minutes and comprises 4-5% of totalsleep time.

1.3 Stage 2 Sleep

Stage 2 is the next stage of sleep and has a higher arousal thresholdthan stage 1. The EEG indicators of stage two are predominantly thetawaves with up to 20% of high voltage delta waves. EEG vertex spikes arecommon, as are sleep spindles with K complexes. The heart rate generallyslows and the body temperature decreases. This stage can last up to 1hour and comprises between 45-55% of total sleep time.

1.4 Stage 3 Sleep

Stage 3 is the beginning of deep sleep. It is characterized by highamplitude delta waves, specifically 20-50% of a 30 sec. periodcomprising EEG waves less then 2 Hz and more then 75 uV. It comprisesbetween 4-6% of total sleep time and generally appears only in the firstthird of the total sleep period.

1.5 Stage 4 Sleep

Stage 4 is the deepest stage of sleep. It is characterized by highamplitude delta waves, the same as Stage 3, except 50% or more of each30 sec. period comprises EEG waves less then 2 Hz and more the 75 uV.Stage 4 comprises 12-15% of total sleep and usually appears only infirst third of sleep period. As this is the deepest stage of sleep, ithas the highest arousal threshold.

1.6 Rapid Eye Movement (REM)

REM sleep is characterized by rapid eye movements and the paralysis ofall postural muscles. EEG recordings are low-voltage, fast-frequency,non alpha, and usually comprise 20-25% of total sleep time. REM is wellknown for being the stage of sleep when dreaming occurs and is thusthought to be strongly linked to mental development and memory. Brainactivity and metabolism is extensive, and there is extensive excitementof the central nervous system. The duration of REM sleep increases witheach subsequent cycle of sleep

2. Characteristics of Quality Sleep

Insufficient or excess duration, significant fragmentation, and anincorrect sleep structure are significant causes of disrupting orinhibiting the essential processes that occur during sleep.

2.1 Duration

It is vital that the patient receives the correct duration of sleep.Both insufficient and excessive sleep duration may have detrimentalhealth effects.

There are differing opinions as to the optimum duration of sleep. Thewidely held belief is that adults require at least 8 hours of sleep pernight to not suffer the effects of sleep deprivation and to remainhealthy. Some studies have suggested 7 hours is optimal, while othertheories suggest that people's sleep need declines with age from amaximum when we are first born, 16 hours, reducing almost linearly toabout 6.5 hours at the age of 70.

Sleeping for less than the optimal duration will cause sleepdeprivation, while sleeping longer than optimal can cause sleep problemsby reducing the drive to sleep and thus reducing sleep efficiency.

Optimum sleep duration appears to be a very individual reading. Manyresearchers believe there may be unknown biological and genetic factorsaffecting people's required sleep duration, in addition to age, sex, andlifestyle demographics. Hence, there is an inter-individual variabilitywhich precludes generalizations.

In one example embodiment, a determination of a patient's optimum sleepduration starts with the outer bounds of 6-9 hours, or with a startingpoint within that range, and then over time isolates the duration,specific to each patient, based on an experience algorithm thatcorrelates the level of daytime sleepiness and actual sleep duration todetermine the optimal duration.

2.2 Fragmentation

There is increasing agreement that the essence of quality sleep iscontinuity and that fragmentation seriously inhibits the essentialprocesses that occur during sleep. This factor is often unrecognized bythe patient as a cause of poor sleep because the subject does notremember the arousals, and thus patients are often unaware that theirsleep has been fragmented and accordingly extremely inefficient.

However, not all arousals should be considered as being disruptive tosleep. All subjects appear to have a certain number of spontaneousarousals which are an intrinsic component of physiological sleep andwhich may still be considered to constitute undisturbed sleep.

Excessive fragmentation can result in significantly altered distributionof sleep stages, the appearance of subjective daytime sleepiness, andobjective performance decrement.

Abnormal fragmentation does lead to the disruption of the sleep processand inhibits the essential processes that occur during sleep.

According to the American Sleep Disorder Association (ASDA) “arousalsare characterized by abrupt changes in EEG frequency, which may includetheta, alpha and/or frequencies greater than 16 Hz but not spindles. Atleast 10 seconds of continuous sleep must precede the EEG arousal, and aminimum of 10 seconds of intervening sleep is necessary to score asecond arousal.

An excessive number of arousals will also disrupt the sleep structure ofthe subject.

2.3 Sleep Structure

As previously stated, having the correct sleep structure is acharacteristic of quality sleep. Each stage of sleep is hypothesized toserve a specific purpose and, therefore, if one stage is reduced or eveneliminated then this will interfere with the specific functions thatoccur during that stage. Conditions such as depression, narcolepsy, andsleep apnea are all characterized by having abnormal sleep structures.

Total sleep time should comprise 4-5% of stage 1, 45-55% of stage 2,4-6% of stage 3, 12-15% of stage 4, and 20-25% of REM. However there aresome external factors that influence sleep structure, and the impact ofthese factors often depends what sleep cycle it is. As sleep progresses,the percentage of REM increases and the duration of stage 3 and 4declines.

Age also significantly affects sleep structure as demonstrated by FIG.3. REM sleep is highest during infancy and early childhood, drops offduring adolescence and young adulthood, and decreases further in olderage. Stages 3 and 4 in the first sleep cycle shorten even moredramatically in older people than they do during a typical night foreveryone else, so older people get less total deep sleep than youngerpeople. Also with age comes the lengthening of the first REM stage.

The optimum sleep structure for each individual patient generally willbe similar to the optimum duration in that it will be specific to eachperson yet most usually within the normal bounds as listed above. Todetermine the optimum sleep structure, a similar method to duration mayalso be used, e.g., start with an assumed optimal sleep structure withinnormal bounds and apply an adaptive algorithm to determine which sleepstructure corresponds to the minimal level of daytime sleepiness.

3. Measurement of Physiological Data

Quantitative determination of physiological sleep session parameters—andthe sleep quality parameters of sleep duration, fragmentation, and sleepstructure—may be measured by the incorporation of an EEG sensor intopositive airway pressure (PAP) and non-invasive ventilation (NIV)apparatus used for the treatment of sleep disordered breathing.

The EEG is a non-invasive method for determining brain activity. Brainactivity causes electrical impulses. These electrical signals aremeasured through electrodes on the patient's scalp/forehead that areconnected to galvanometers. As previously discussed, the differentstages of sleep can be characterized by their signature EEG signals.

Modern EEGs have been reduced to a single channel and only threeelectrodes need now be placed below the hairline, as opposed toattaching the electrodes to the scalp as required in older EEGtechnology. Examples of EEG measurement apparatus suitable for use inthe present embodiments include the BioSomnia Plus by Oxford BioSignalsLimited of Oxford, UK.

The EEG electrodes may be incorporated into the soft components of theapparatus, such as the headgear, mask cushions, or nasal prongs. Thedata from the EEG sensors may be sent by wire running along the gas flowtube to a processor built into the flow generator for processing andanalysis, or may be transmitted using wireless technology.

One alternative to the use of EEG for monitoring of the physiologicaldata is the use of pulse plethysmographs (otherwise known as pulseoximetry), which may also provide other useful information on centralnervous system activation.

Sensors and techniques which may be used to measure the patient'sphysiological sleep session data may include one or more of thefollowing:

3.1 Duration-Related Sensors

Timer—the timer of the flow generator may be used to measure: time themachine is turned on to time it is turned off; time from the first apneaprevention to when it is turned off; time from first apnea prevention totime to last apnea prevention, etc.

EEG—as discussed above, an EEG apparatus may measure brainwaves todetermine sleep onset and arousal and hence calculate duration.

Electromyography—may be used to detect muscle movement and therefore candetect arousal if arousal is defined by a movement threshold.

Electro-Oculogram—measures eye movement and hence can determine durationif it is assumed that the detection of slow eye movement determines theonset of sleep, to detect arousal from sleeping to wakefulness, etc.

Facial Recognition Sensors—may be used to detect sleep duration bychanges in the patient's face between sleep and wakefulness.

Accelerometer—may be mounted on the patient to detect transition fromwakefulness to sleep by noting a change in the level of movement of thepatient.

Pulse oximeter—measures pulse and also blood oxygen levels. Differentpulse rates may mark the difference between resting and awake,optionally used in conjunction with other sensors to validate results.

3.2 Fragmentation-Related Sensors

Accelerometer—as discussed above, may be used to measure movement andhence detect arousal accompanied by movement.

EEG—may measure brainwaves to determine sleep onset and arousal andhence calculate fragmentation.

Pressure and flow sensors, such as those used in current flow generatortechnology, may be used to determine apneas and hence detect arousals.

3.3 Sleep Structure Related Sensors

Electro-Oculogram—may be used to detect rapid eye movement sleep.

Facial Recognition—may detect REM, where resolution is high enough todetect eye movement.

Accelerometer—measures movement and detects REM sleep by the lack ofmovement, as no movement occurs during REM sleep.

Pulse oximeter—measures pulse and also blood oxygen levels. Differentheart rates may correspond to different stages in sleep, optionally withcorrelation to other sensor results.

Also, currently known techniques to monitor apneas may be used, withcorrelation between the number of times the device has to prevent anapnea and the stage of sleep.

3.4 AHI

Currently known techniques for measuring AHI may be used. Alternatively,or additionally, AHI may be detected from a combination of sleepstructure and fragmentation techniques described above, with an AHIevent being inferred from an arousal or by an unexpected transition fromone sleep state to another.

3.5 Sleep Latency

The same techniques mentioned above for duration may be used, exceptwith the sleep latency measurement being taken from the time the machineis turned on to the time it is registered that the patient is sleeping,or optionally from the time that the patient indicates he or she isattempting to sleep, if the patient is reading, etc., prior toattempting to sleep.

3.6 Snore Results

Microphone—recognition of snoring by microphone is advantageous in thatit is applicable for patients who are not using flow generator.

Pressure and flow sensors—snore measurement utilizing current flowgenerator techniques may be used.

4. Collecting Patient Feedback Data

The patient may be quizzed at the end of each sleep session, at apredetermined time during the day, and/or before commencement of thenext session, to provide subjective data concerning sleep quality andsleepiness. This feedback may conveniently be collected using thegraphical interface and controls of the flow generator, or alternativelyvia a communication link to a separate interface device such as theHealth Buddy device manufactured by Health Hero Network, Inc. ofMountain View, Calif., USA. The questions may, for example, be similarto those used in the Epworth Sleepiness Scale.

5. Calculating the Overall Sleep Quality Index

FIG. 4 is an overview of the calculation of a composite sleep qualityindex (SQI) according an example embodiment.

As a first step, the patient's physician programs the patient's profiledata—e.g., data that will remain relatively static over numeroustreatment sessions, such as, for example, age, sex, weight, ethnicity,and severity of diagnosed sleep disordered breathing—into the CPAP flowgenerator. This programming may be done at the physician's premises orremotely by a communications link such as a modem line or other suitablenetwork connection.

The sleep session physiological data from the EEG is collected while thepatient sleeps and is stored in the processor or a computer-readablestorage medium (e.g., a memory, disk drive device, smart card, etc.) ofthe flow generator. This physiological data forms the basis ofcalculation of a composite sleep quality index score.

In calculating the sleep quality score according to an exampleembodiment, the following parameters may used: duration, fragmentation,sleep structure, AHI, sleep latency, and/or snore results.

Generally, duration, fragmentation, and sleep structure will give thebest indication of sleep quality. However, sleep quality could bedetermined on the basis of any one of the parameters alone.

Each parameter is given a score based on their value compared to anoptimal value for that patient. Initially, the optimal values againstwhich the individual parameters are scored will be determined primarilyby the normal population results, as modified by the patient profiledata. The scores set out in the tables below for each parameter areestimated. Also, sample scores are set out in the series of tablesbelow.

5.1 Duration

The optimum duration may initially be set at 8 hours. However, this maybe altered as the algorithm learns the optimum duration for theindividual patient.

Duration Score Rank Optimum less 2+ hours 0 6 Optimum less (2-1) hours 35 Optimum less (1-0) hours 6 4 Optimum 10 1 Optimum + (0-1) hours 9 2Optimum + (1-2) hours 7 3

5.2 Structure

Structure Score Insufficient REM sleep 5 Insufficient Stage 3 & 4 5Optimum 10

5.3 Fragmentation

Excessive fragmentation decreases the quality of sleep and can bethought to have the same effect as decreased duration. Hence, in thepresent example, fragmentation affects the value of duration that isused in the quality calculations. The patient's age should be taken intoaccount here, for example, as the average number of arousals that isacceptable increases with age.

Fragmentation New Value for Duration >60 per hour 0.4 * Duration 31-59per hour 0.6 * Duration 21-30 per hour 0.85 * Duration  15-20 per hour0.9 * Duration 10-14 per hour Duration 5-9 per hour Duration 0-4 perhour Duration

5.4 Sleep Latency

Sleep latency is the time it takes to get to get to sleep. The time tofall asleep that is considered to be normal is about 15 minutes. Thestarting point for measurement of sleep latency may be the commencementof PAP treatment, or alternatively some other signal may be used, forexample, having the patient press a button on the flow generator controlpanel.

Sleep Latency Time Score >1.5 hours 0 1-1.5 hours 2 45-1 minutes 4 30-45minutes 6 15-30 minutes 8 0-15 minutes 10

5.5 AHI

The apnea hypopnea index (AHI) is the number of apneas or hypopneas thata patient suffers per hour. Generally, an AHI of greater than 5 isbelieved to indicate sleep apnea.

AHI Score 0-5 10  5-20 7 21-50 4 >51 0

5.6 Snore

The snore parameter is a measurement of the number of times a patientsnores throughout the treatment period. In order to ensure that speakingand other activities are not falsely recorded as snoring, the EEG may berequired to register that a patient is asleep before detecting snore.

Occurrence of Snoring Score 0-5 10  6-10 7.5 11-15 5 16-20 2.5 >21 0

Other parameters which may be measured as indicators of sleep qualityinclude heart rate, blood oxygen saturation, skin temperature, movement,respiration rate, muscle tone/tension, etc.

5.7 Total Calculation

The above measured scores are weighted according to relative importanceto sleep quality and tallied to give a total sleep quality index score,for example, out of a total of 100.

In one example of the calculation:

Sleep Quality Index=(Fragmentation AlteredDuration)*A+AHI*B+Structure*C+Snore+Latency

It should be noted that the weightings A, B, and C are adjustable. Inone typical example: A=4, B=2, and C=2. Of course, it will beappreciated that the formula and weightings are presented by way ofexample and without limitation.

5.8 Adaptation of Sleep Quality Scores and/or Weighting

As the patient's treatment continues, the optimal values for calculationof the scores for the measured sleep session parameters may be modifiedby correlation of the subjective data results against the physiologicaldata for the previous sleep session or sessions, as the system evolvesto “learn” the exact criteria that corresponds to healthy sleep for theindividual patient. For example, if it becomes apparent that the patientfeels best the next day after 7 hours sleep rather than 8 hours, theduration scores will be modified to set 7 hours as the optimal durationfor that patient.

Alternatively, or additionally, if the subjective feedback results showthat the patient is unusually tolerant of arousals, or of disruptedsleep structure while still feeling refreshed the next day, the amountby which the fragmentation discounts the duration may be reduced.

Still further, if the correlation of the measured data and feedback datashows that the patient is particularly tolerant, or intolerant, of oneof the component factors discussed above, the weighting of thatparameter in calculation of the sleep quality index may be modifiedaccordingly. Thus, it will be appreciated that in certain exampleembodiments, the calculation of sleep quality scores may be adjustedover time by varying the relative weightings and/or presence of certainvariables.

6. Display of Results

The sleep quality index results may be communicated in any suitablemanner to the patient, for example, graphically or audibly. For example,in an example embodiment, the results may be displayed graphically onthe display of the flow generator, e.g., they may be called up as partof the menu structure of the machine.

The results may also be able to be downloaded to media or sentelectronically by email or similar mechanisms to the patient's orclinician's computer. Where the patient's employment is safety-critical,for example, such as for long distance drivers or pilots, informationmay be sent to the employer's computer.

The sleep quality index may be displayed in any form which will bereadily understood by the patient, for example, as a score out of 10 or100, or as a rating out of 5 stars, as a graph, a row of lights, asdifferent colors, etc.

The display may include a display of the individual sleep parametermeasurements and/or their scores, as well as of the composite sleepquality index value, however displayed. Also, the display may allow acomparison of the sleep quality index values and/or the individualparameters across a range of sleep sessions or over a longer timeframe,for example, by the use of graphs.

The processor may also be configured to extrapolate using improvementsto the patient's sleep quality index, for example, to show what effectany lifestyle and/or sleep hygiene changes (e.g., improvements orneglect, for example) are having on average life span, healthstatistics, likely work or sports performance, etc.

The sleep quality index may be used as a tool to teach patients toimprove their sleep hygiene therefore enabling sleep disorder treatmentto provide better results, the overall result being to involve patientsin their treatment and to give them a sense of ownership and empowermentover their own treatment.

By providing the patient with an indicator of his or her sleep healthwhich is meaningful to the patient, it is expected that there will be anincrease in compliance with therapy related to educating and involvingpatients in their treatment and assisting the patients through thedifficult adoption period where there is currently a high drop out rate.Similarly, it is expected that an apparatus incorporating the SQI willbe useful as a tool to encourage and educate users, dynamicallycommunicating the significant benefits of treatment and allowingpatients, clinicians, partners, and caregivers to clearly see how thesleep and overall health has improved since the start of treatment.

By providing substantial real-time feedback that indicates how healthand lifestyle changes are affecting their body and sleep patterns, theSQI may also have the effect of encouraging patients to improve theiroverall health.

FIG. 5 is an illustrative flowchart showing a process for determiningsleep quality index and communicating sleep quality data to at least apatient in accordance with an example embodiment. Data is collected fromthe patient and/or physician in step S502. Such data may include, forexample, sleep session data in the form of one or more physiologicalparameters of the patient indicative of the patient's sleep qualityduring the sleep session, a subjective evaluation of sleep quality madeby the patient, etc.; patient profile data; and/or the like. The datamay be input before and/or after a treatment session and/or a treatmentregimen, etc. It may be gathered via manual input (e.g., to an interfacelocated on or remote from the treatment device), automatically (e.g.,from a treatment device substantially without direct user input), etc.

In step S504, a sleep quality index algorithm is applied. The sleepquality index algorithm may be an adaptive algorithm that takes intoaccount some or all of the data collected in step S502. Sleep qualitydata may be presented to at least the patient in step S506. This sleepquality data may be displayed in any suitable format, e.g., a formatuseful for the patient to be appraised on the progress of the treatment,a format useful for a sleep clinician to monitor progress and/or assessthe effectiveness of differing treatment regimens, etc. Optionally instep S508, the treatment and/or the algorithm may be adjusted, forexample, based on the data. In this way, a patient also may be able tomore concretely “see” the real effects of changes in treatment,lifestyle, etc.

FIG. 6 is an illustrative block diagram showing an apparatus 600 fordetermining sleep quality index and communicating sleep quality data toat least a patient in accordance with an example embodiment. Theapparatus 600 includes a processor 602. The processor 602 may receiveinput from a user interface 604 and/or a PAP device 608. This input mayinclude, for example, sleep session data in the form of one or morephysiological parameters of the patient indicative of the patient'ssleep quality during the sleep session), a subjective evaluation ofsleep quality made by the patient, etc.; patient profile data; etc.Optionally, the processor 602 may be configured to receive data from aremote source (e.g., via a transceiver, not shown in FIG. 6). Theprocessor 602 may perform a calculation to arrive at a sleep qualityindex. To facilitate the storage of information and/or calculation ofthe sleep quality index, a computer-readable storage medium 606 (e.g., amemory, disk drive device, flash drive, smart card, etc.) may beprovided to the apparatus 600. Display programmed logic circuitry 610also may be provided to the apparatus 600 to display, for example, thesleep quality index, changes in the sleep quality index over time,interface screens in connection with the user interface 604, etc. Theformat of the display of information may be adjusted in dependence onuser input in certain example embodiments. It will be appreciated thatthe above-described components may be implemented as any suitablearrangement of programmed logic circuitry (e.g., software, hardware,firmware, and/or the like, and/or any suitable combination thereof).

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments.

Also, the various embodiments described above may be implemented inconjunction with other embodiments, e.g., aspects of one embodiment maybe combined with aspects of another embodiment to realize yet otherembodiments. In addition, while the invention has particular applicationto patients who suffer from OSA, it is to be appreciated that patientswho suffer from other illnesses (e.g., congestive heart failure,diabetes, morbid obesity, stroke, barriatric surgery, etc.) can derivebenefit from the above teachings. Moreover, the above teachings haveapplicability with patients and non-patients alike in non-medicalapplications.

1.-18. (canceled)
 19. A method of assessing sleep quality of a patientin a sleep session, the method comprising: by way of a sensor, obtainingsleep session data comprising at least one physiological parameter ofthe patient indicative of the patient's sleep quality during a firstsleep session in which the patient undergoes therapy; by way of aprocessor, calculating a first sleep quality index by comparing thesleep session data to a predetermined optimum value in order todetermine a score index for the at least one physiological parameter;prompting the patient to input subjective patient data into a userinterface; by way of the processor, adjusting the predetermined optimumvalue to a new optimum value for a future sleep session based on thesubjective patient data; and communicating the first sleep quality indexto at least the patient or a healthcare provider.
 20. The method ofclaim 19, wherein communicating further comprises displaying the firstsleep quality index on the display.
 21. The method of claim 19, whereincommunicating further comprises transmitting the first sleep qualityindex wirelessly to another electronic system.
 22. The method of claim19, wherein the at least one physiological parameter includes at leastsleep duration and sleep fragmentation.
 23. The method of claim 22,wherein the subjective patient data includes a first value correspondingto sleep duration and a second value corresponding to sleepfragmentation.
 24. The method of claim 19, wherein said calculatingoccurs by the score index for each of the at least one physiologicalparameter.
 25. The method of claim 19, further comprising storing, byway of the processor, a ranked order of stored values corresponding tothe at least one physiological parameter, wherein each stored valueincluding a corresponding score index.
 26. The method of claim 25,wherein adjusting the predetermined optimum value to a new optimum valuechanges the corresponding score index corresponding to at least onestored value of the stored values.
 27. The method of claim 19, whereinthe at least one physiological parameter is multiple physiologicalparameters, and wherein said calculating is further practiced byperforming a relative weighting of the multiple physiologicalparameters.
 28. The method of claim 27, wherein said relative weightingof the multiple physiological parameters is dependent on patient profiledata.
 29. The method of claim 28, wherein said patient profile dataincludes at least one of: patient age, sex, weight, ethnicity, and sleepdisorder data.
 30. The method of claim 27, wherein said relativeweighting of the multiple physiological parameters is dependent on thesubjective patient data.
 31. The method of claim 19, further comprising,comparing a subsequent sleep quality index calculated in a subsequentsession to the first sleep quality index; by way of the processor,extrapolating at least one patient characteristic based on a changebetween the first sleep quality index and the subsequent sleep qualityindex; and outputting the at least one patient characteristic on thedisplay, wherein the at least one patient characteristic is configuredto provide data to the patient regarding effects of sleep hygiene and/orlifestyle changes.
 32. The method of claim 31, wherein the at least onepatient characteristic includes average expected life span, expectedwork performance, and/or expected athletic performance.
 33. The methodof claim 19, further comprising communicating feedback to the patient bydisplaying information on the display to the patient regardingimprovements for future therapy sessions; and making adjustments tofuture therapy sessions based on the feedback provided to the patient;wherein said information includes directions for modification to therapysettings for subsequent therapy sessions.
 34. An apparatus for assessingsleep quality of a patient while undergoing therapy for a sleep disorderbreathing, the apparatus comprising: a PAP device configured to supplybreathable gas under pressure to the patient for treatment of sleepdisorder breathing; at least one sensor configured to obtain sleepsession data comprising at least one physiological parameter of thepatient indicative of the patient's sleep quality during a first sleepsession in which the patient undergoes therapy; and a processorconfigured to: calculate a first sleep quality index by comparing thesleep session data to a predetermined optimum value in order todetermine a score index for the at least one physiological parameter;prompt the patient to input subjective patient data into a userinterface; adjust the predetermined optimum value to a new optimum valuefor a future sleep session based on the subjective patient data; andcommunicate the first sleep quality index to at least the patient or ahealthcare provider.
 35. The apparatus of claim 34, wherein theprocessor is further configured to store a ranked order of stored valuescorresponding to the at least one physiological parameter, wherein eachstored value including a corresponding score index.
 36. The apparatus ofclaim 35, wherein adjusting the predetermined optimum value to the newoptimum value changes the corresponding score index corresponding to atleast one stored value of the stored values.
 37. The apparatus of claim34, wherein the at least one physiological parameter includes at leastsleep duration and sleep fragmentation.
 38. The apparatus of claim 34,wherein the at least one physiological parameter includes multiplephysiological parameters, wherein the processor is configured to promptthe patient to input subjective patient data related to eachphysiological parameter of the multiple physiological parameters, andwherein the processor is configured to adjust the optimum value relatedto each physiological parameter based on the respective subjectivepatient data.